Kate McDonnell's Contact Details

Kate McDonnell's Company Details

NCGS, Inc.

Charleston, SC, US • 250 - 499 Employees
Major Drugs

NCGS, Incorporated is a full-service international CRO managing clinical trials since 1984 in drug, biologic, device, diagnostics and consumer products. NCGS provides full-service or strategic sourcing needs focused on risk mitigation. Contingency planning is actively employed, not just planned for. NCGS is a WBENC certified diversity supplier.NCGS has supported the development or expanded labeling of 78 approved products and has ZERO 483s. NCGS clinical teams are first in class, highly- tenured professionals - 10+ years' experience; A team remains throughout the trial- Turnover rates are discernibly different at less than 3% annuallyCLINICAL TRIAL THERAPEUTIC FOCUS INCLUDES: - Neuro-Psych (CNS)- Infectious Diseases / Critical Care- Oncology, hematology, transplant- Trials in multiple other areas have been conducted ROBUST DIVISION OF COMPLIANCE & RECRUITMENT SPECIALIST- CAPA initiatives- Due diligence auditing - eTMF- Subject recruitment- Call Center 24/7- Trial Rescue- Safety, SAE narratives and SAE reconciliationFULL SERVICES INCLUDE:• Clinical Operations and Monitoring• Fully Integrated e-Based iCloud Systems- e-REMOTE: Risk-based monitoring- eTMF: TMF Migration, Consolidation- ePAY: Grants, Contracts, Payments- eDM: EDC, IWRS- ePRO:Patient Reported Outcomes- eCLIN: CTMS• Medical Monitoring & Clinical Safety • Quality Assurance & Regulatory Compliance• Global Strategic Sourcing• Medical Writing• Biostatistics